Implantable electrical stimulator with deflecting tip lead

ABSTRACT

In some examples, an implantable medical device includes an implantable housing, a neurostimulator within the housing, a plurality of electrodes, an implantable lead coupled to the housing, and an actuator formed with the housing. The implantable lead includes at least one electrode of the plurality of electrodes and one or more conductors coupling the at least one electrode to the neurostimulator. The actuator is configured to cause at least a portion of the implantable lead to deflect.

This application claims the benefit of U.S. Provisional Application No.62/254,516, filed Nov. 12, 2015, the entire content of which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

The disclosure relates to medical devices and, more particularly,implantable electrical stimulators with leads carrying electrodes.

BACKGROUND

Implantable medical devices may be configured to deliver electricalstimulation therapy and/or monitor physiological signals. Electricalstimulation of nerve tissue, for example, may provide relief for avariety of disorders, improving the quality of life for many patients.

Some implantable medical devices may employ elongated electrical leadsthat carry electrodes. For example, electrodes may be located at adistal portion of a lead. A proximal portion of the lead may includeelectrical contacts that are coupled to the electrodes via conductorswithin the lead and coupled to terminals in an implantable medicaldevice housing, which may contain electronic circuitry such aselectrical stimulation generation circuitry and/or sensing circuitry.

Electrical stimulation may be delivered for spinal cord stimulation(SCS), peripheral nerve stimulation (PNS), peripheral nerve fieldstimulation (PNFS), deep brain stimulation (DBS), cortical stimulation(CS), pelvic floor stimulation, gastric stimulation, and the like.

SUMMARY

The disclosure is directed to a method for implanting a lead of animplantable medical device with a deflecting tip adjacent to a nerve ofa patient. The disclosure is also directed to an implantable medicaldevice comprising a combination of an electrical stimulator, a lead witha deflecting tip, and an actuator configured to cause the tip todeflect.

In one example, the disclosure is directed to an implantable medicaldevice including an implantable housing, a neurostimulator within thehousing, a plurality of electrodes, an implantable lead coupled to thehousing, and an actuator formed with the housing. The implantable leadmay include at least one electrode of the plurality of electrodes andone or more conductors coupling the at least one electrode to theneurostimulator. The actuator may be configured to cause at least aportion of the implantable lead to deflect.

In another example, the disclosure is directed to a method ofpositioning an implantable medical device within a patient. Theimplantable medical device may include an implantable housing, aneurostimulator within the housing, a plurality of electrodes, and animplantable lead coupled to the housing. The implantable lead mayinclude at least one electrode of the plurality of electrodes and one ormore conductors coupling the at least one electrode to theneurostimulator. The method may include deflecting at least a portion ofthe implantable lead in response to movement of an actuator formedwithin the housing.

In yet another example, the disclosure is directed to an implantablemedical device including an implantable housing, a neurostimulatorwithin the housing, a plurality of electrodes, an implantable leadcoupled to the housing, and a means, formed within the housing, forcausing at least a portion of the implantable lead to deflect. Theimplantable lead may include at least one electrode of the plurality ofelectrodes and one or more conductors coupling the at least oneelectrode to the neurostimulator.

The details of one or more examples of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating an exemplary implantablemedical device (IMD), having an implantable neural electrical stimulator(INS), a lead with a deflecting tip, and an actuator for causing the tipof lead 30 to deflect, and a method of inserting the deflecting tip ofthe lead adjacent a nerve site of the patient.

FIG. 2 is a schematic diagram illustrating the exemplary deflecting tipof the lead of FIG. 1 upon insertion through the sacral foramen to reacha sacral nerve.

FIG. 3 is a schematic diagram illustrating an exemplary electrical leadof the IMD of FIG. 1 inserted through the sacral foramen and disposedadjacent to a sacral nerve after removal of an introducer.

FIGS. 4A and 4B are views of an exemplary IMD with a lead having adeflecting tip and a sliding actuator configured to cause the tip of thelead to deflect to implant the lead adjacent to a nerve.

FIG. 5 is a view of an exemplary IMD like that shown in FIGS. 4A and 4Band additionally including a pulley.

FIGS. 6A and 6B show perspective and cross-sectional views of anexemplary ratcheting system of the IMDs of FIGS. 1 and 4A-4C.

FIG. 7 shows a perspective view of another exemplary ratcheting systemof the IMDs of FIGS. 1 and 4A-6A.

FIG. 8 shows a perspective view of an exemplary IMD like that shown inFIGS. 1 and 4A-7 and additionally including a tool for holding anactuator, which may be in the form of a collar, of the IMD in place.

FIG. 9 shows a perspective view of an additional exemplary ratchetingsystem of the IMD of FIG. 1.

FIGS. 10A-10C show perspective and side cross-sectional views of anadditional exemplary ratcheting system of the IMB of FIG. 1.

FIGS. 11A and 11B show perspective and side cross-sectional views of anadditional exemplary ratcheting system of the IMB of FIG. 1.

FIGS. 12A-12E show views of another exemplary IMD with the lead having adeflecting tip and a rotating actuator configured to cause the tip todeflect to implant the electrical lead adjacent to a sacral nerve.

FIG. 13 shows a view of an exemplary IMD with a lead having a deflectedtip.

FIGS. 14A-14C are conceptual diagrams illustrating exemplary electricalleads with deflecting tips useful in the examples of FIGS. 1-13 andfurther including tines to secure the lead within a patient.

FIGS. 15 and 16 are block diagrams illustrating exemplary electricalstimulators configured for use with a lead with a deflecting tip in anIMD useful in the examples of FIGS. 1-14C.

FIG. 17 is a flow chart illustrating an example technique for implantinga lead of an implantable medical device with a deflecting tip adjacentto a sacral nerve.

DETAILED DESCRIPTION

FIG. 1 is a schematic diagram illustrating an exemplary implantablemedical device (IMD) 24 having an implantable neural electricalstimulator (INS) 29, a lead 30 with a deflecting tip, and an actuator 28for causing the tip of lead 30 to deflect.

FIG. 1 also illustrates a method of inserting the deflecting tip of lead30 adjacent a nerve site of the patient. In the example of FIG. 1, thedeflecting tip of lead 30 is inserted through a sacral foramen 20 of thepelvis 10 of a human patient, e.g., for sacral nerve stimulation. Lead30 may comprise one or more electrodes arranged for unipolar, bipolar,or multipolar stimulation. In the example of a unipolar lead with one ormore electrodes, a second one or more electrodes may be housed inhousing 26. IMD 24 of FIG. 1 represents an example of an IMD comprisingan implantable housing, a neurostimulator within the housing, aplurality of electrodes, an implantable lead coupled to the housing andcomprising at least one electrode of the plurality of electrodes and oneor more conductors coupling the at least one electrode to theneurostimulator, and an actuator formed in the housing and configured tocause at least a portion of the implantable lead to deflect.

Urinary incontinence, fecal incontinence, sexual dysfunction, pelvicpain and other pelvic floor disorders are common problems afflictingpeople of all ages, genders, and races. Many of the disorders may beassociated with aging, injury, or illness. In some cases, pelvic floordisorders can be attributed to improper nerve function. For example,aging can often result in nerve disorders that prevent proper operationof the bladder, sphincter muscles, or sexual organs. Nerves, such as thesacral nerve, pudendal nerve, or branches of the pudendal nerve, runningthough the pelvic floor regulate urinary and sexual function. Urinaryincontinence or sexual dysfunction can arise when there is breakdown incommunication within the nervous system.

Electrical stimulation of nerves in the pelvic floor may provide aneffective therapy for a variety of disorders. For example, a surgeon mayimplant an electrical stimulation lead adjacent to the sacral nerve,pudendal nerve, or branches of the pudendal nerve. An implantableelectrical stimulator, sometimes referred to as a neurostimulator, maybe provided to deliver electrical stimulation through the lead. In thecase of urinary incontinence, as an example, the stimulation may induceurinary sphincter constriction or reduce bladder wall constriction toaid the patient in reducing unwanted urinary voiding.

Also, the stimulation may be effective in restoring sexual function oralleviating pelvic floor pain. As another example, the stimulation maybe effective in reducing pelvic pain. Stimulation leads are ordinarilyimplanted surgically or percutaneously.

A physician may deflect the tip of the lead to place the lead at thetarget nerve site and perform test stimulation to confirm an effectivestimulation location. After placing the lead at the target nerve site,the introducer may be removed and the lead along with the implantablemedical device may be implanted by the physician. This placement andimplantation method may provide an easier and more consistent procedurethan a placement procedure that requires an implant tool.

Electrical stimulation of the sacral nerve may provide therapy forpatients experiencing urinary incontinence, urinary retention, boweldisorders such as fecal incontinence, constipation, sexual dysfunction,or other pelvic floor disorders related to pelvic nerve function. Theprocedure described herein may also be directed to the implantation ofelectrical leads adjacent to other sacral nerves or other nerves nearthe sacrum. For example, the nerve of the clitoris may be accessed andstimulated to treat sexual dysfunction. In addition, the procedure maybe applied to female or male patients. The IMD may also be used forstimulation in other areas of the body, according to particular needs.For example, an IMD having a lead with a deflecting tip, as described inthis disclosure, may be used for various types of stimulation, such asspinal cord stimulation (SCS), peripheral nerve stimulation (PNS),peripheral nerve field stimulation (PNFS), deep brain stimulation (DBS),cortical stimulation (CS), gastric stimulation, and the like. As oneexample, the deflecting tip of the device described herein may be usedto better access anatomy of the heart including, for example, the leftventricle of the heart.

In various examples, an IMD formed in accordance with this disclosuremay provide one or more advantages. For example, the IMD may provide aneasier and more consistent procedure for implanting the stimulation leadnear a nerve, such as the sacral nerve in pelvic floor applications. TheIMD may also reduce the risk of nerve tissue damage associated withother lead implantation procedures. In addition, an improved IMD may notonly decrease the time and cost associated with lead implantation, butincrease the number of patients who may utilize sacral nerve or otherpelvic floor nerve stimulation to treat a variety of conditions.Further, implantation may utilize established skills of the physician.Additional advantages may include more secure placement of a lead. Insome cases, external imaging techniques such as fluoroscopy may beunnecessary to achieve proper lead placement.

Combining an INS, a lead configured to deflect, and an actuator fordeflecting the lead into a single, implantable device may allow for asimple and efficient implant procedure and ongoing therapy. For example,combining the elements into a single, implantable device may reduce thenumber of steps, amount of time, and number of tools used for theimplant procedure, while still allowing for satisfactory placement ofthe lead adjacent to a target nerve site. The device may eliminate theneed for tunneling, pocket creation, and implantation of an IPG. Thesimplified implant device using the combined system may allow for aprocedure using only local anesthesia, reduced bleeding, and anoffice-based procedure. The device may eliminate the need for an openport during trial use to allow for a smooth transition from trial use tochronic use without additional surgery and to allow for more predictablechronic results based on trial results. In some examples, the device maybe externally powered at a patient's convenience and according totherapy needs to allow for more convenient and effective therapy andimproved outcomes.

Additionally, reliability may be improved by, for example, reducing thechance of faulty electrical connection between the lead and the INS. Forexample, using conventional systems including a lead that must beimplanted before connection to an INS, a physician may need to properlyinsert the lead and then maintain alignment of the lead whilesimultaneously electrically connecting it to the INS by, for example,connecting connectors of the lead and the INS using a mechanical locksuch as a set screw. This process may be susceptible to errors includingmisaligned or unaligned electrical connectors or crushed connectorrings. Combining the elements into a single, implantable deviceeliminates the need for the physician to electrically connect the leadto the INS and may thus reduce the chance of faulty connections andimprove reliability.

As shown in FIG. 1, an anterior view of pelvis 10 includes sacrum 14,inferior pubic ramus 16, ischial tuberosity 18, sacral foramen 20, andacetabulum 22. IMD 24 includes housing 26, an actuator 28 in a ratchetsystem 27, an electrical stimulator in the form of implantableelectrical neural stimulator (INS) 29, and lead 30. An introducer 31 maybe used to introduce IMD 24 into the body of a patient. IMD 24 may beused by a surgeon to locate a nerve in pelvis 10 for the purpose ofimplanting lead 30 that stimulates the nerve with INS 29. Lead 30covered by introducer 31 (e.g., a sheath) in the example of FIG. 1, isinserted through sacral foramen 20 to access sacral nerves of a patient.In this manner, lead 30 supports access to the sacral nerves. Pelvicnerves may include sacral nerves, pudendal nerves, or branches ofpudendal nerves, and other pelvic nerves. Upon placing lead 30 adjacenta suitable nerve site, IMD 24 may be implanted chronically (e.g., forweeks, months, or years) or temporarily (e.g., for hours, days, orweeks) within the patient to deliver long-term or short-term electricalstimulation therapy. Short-term therapy may include trial therapy toevaluate prognostic efficacy of the electrical stimulation therapy ortherapy of a prescribed short-term duration. IMD 24 may be explantedfrom the patient, or left implanted, upon completion of the short-termtherapy.

IMD 24 may be used to reach a wide variety of nerves which can beaccessed by the surgical procedure described herein. Pelvic floorstimulation will be described for purposes of example, but withoutlimitation as to the use of IMD 24 in other stimulation applications,such as for spinal cord stimulation (SCS), peripheral nerve stimulation(PNS), peripheral nerve field stimulation (PNFS), deep brain stimulation(DBS), cortical stimulation (CS), gastric stimulation, and the like.

For pelvic floor stimulation, example nerve targets include the sacralnerve, the pudendal nerve, various branches of the pudendal nerve, thenerve of the clitoris, as well as other pelvic nerves. IMD 24 may beimplanted within a patient with lead 30 positioned proximate a targetnerve or nerves within pelvis 10. In some cases, the shape of IMD 24 maybe modified to facilitate lead placement proximate a target nerve ornerves. For example, a tip of lead 30 may be deflected with deflectionactuator 28 and ratchet system 27 to facilitate lead placement proximatea target sacral nerve or other nerve located within the pelvis. In thisexample, the deflection of lead 30 may cause the distal tip of lead 30,and introducer 31, to change from a first shape to a second shape. Uponlocation of a distal end of lead 30 proximate to the target nerve ornerves, introducer 31 may be removed from lead 30 and IMD 24 may beimplanted in the patient. Introducer 31, or any other introducerdescribed herein, may be any object that is introduced into or otherwisepenetrates tissue of the patient and provides an insertion channel forlead 30 and/or housing 26 to travel into the patient.

In the example of pelvic floor implantation, the sacral nerves are foundwithin sacrum 14 and exit the sacrum anterior through a foramen (hole).The sacral nerves exit laterally and caudally from the sacral foramen.Minimally invasive methods for implanting an electrical lead adjacentthe sacral nerve are preferred, but may be difficult to perform. Inaddition, the use of imaging equipment to implant the electrical leadmay be cumbersome or impractical in some cases. Advantageously, unlike astraight needle, using the method and device described in thisdisclosure, a physician may be able to deflect the tip of lead 30 withdeflection actuator 28 to accurately locate the tip of lead 30 adjacentto the sacral nerve. In this manner, IMD 24 allows the physician tosuccessfully locate the sacral nerve, effectively positioning the lead30 adjacent the sacral nerve, remove introducer 31 from lead 30, andimplant IMD 24.

A procedure using IMD 24 is preferably performed on a patient havingnormal anatomical soft tissue covering pelvis 10 such as muscle, bloodvessels, organs, and skin. FIG. 1 is for illustrative purposes and showspelvis 10 without soft tissue surrounding pelvis 10. Local or generalanesthetics may be administered to minimize pain perceived by thepatient.

Introducer 31 of lead 30 may pierce skin in the lower back of thepatient. Once underneath the skin, the physician may advance lead 30 ofIMD 24 in the direction of the arrow through sacral foramen 20 to theapproximate location of the sacral nerve. In some examples, thephysician may deflect the tip of lead 30 with deflection actuator 28 andratchet system 27 to better locate lead 30 adjacent to the target nervesite. In the case of different nerves, i.e., other than the sacral nerveassociated with sacral foramen 20, a different deflection of a portionof lead 30 near a distal tip of lead 30, relative to a majorlongitudinal axis of the lead, may aid in directing lead 30 to theappropriate nerve site. Hence, where lead 30 may have a majorlongitudinal axis, deflection may refer to at least some deviation fromthe major longitudinal axis. If the longitudinal axis of lead 30 isassumed to be at a reference angle of 0 degrees, the deflection mayresult in deviation of a distal portion of the lead 30 by an angle of ina range of approximately 10 degrees to 60 degrees, and in anotherexample, 35 degrees to 55 degrees, relative to the reference angle ofthe major longitudinal axis. In some examples, deflection may result inone or more electrodes being displaced from the major longitudinal axisby a distance in the range of 0.1 mm to 20 mm, and in another example,0.5 mm to 1.5 mm.

For example, in the case of deflecting the distal portion of lead 30 tobe adjacent to a sacral nerve, the sacral nerve may divert from theforamen axis by approximately 45 degrees. Thus, if lead 30 is placedsuch that its major longitudinal axis is substantially aligned with anaxis passing through the foramen at an angle substantially perpendicularto the major plane of the foramen opening, the distal portion of thelead 30 may be deflected by an angle of approximately 45 degrees inorder to position the distal portion adjacent to the sacral nerve. Iflead 30 is positioned such that the major longitudinal axis is notsubstantially aligned with the foramen axis, the distal portion of lead30 may need to be deflected substantially more or less than 45 degreesrelative to the foramen axis in order to position the distal portion oflead 30 adjacent to the sacral nerve.

Housing 26 is shaped to allow a physician to hold it with at least onehand. Ratchet system 27 and deflection actuator 28 are also provided tosupport the deflection of the distal end of lead 30. Ratchet system 27may be configured to allow a physician to deflect the tip of lead 30with one hand and retain the deflection curve of lead 30 until thephysician intentionally adjusts deflection actuator 28. In other words,ratchet system 27 prevents or minimizes unintentional changes to thedeflected tip of lead 30. This may be particularly important afterimplantation to prevent unwanted changes in the deflection of the tip oflead 30. In some examples, ratchet system 27 may comprise a ratchetsystem or any other mechanical device that allows motion, e.g., linearor rotational, in one direction while preventing motion in the oppositedirection. For example, ratchet system 27 may allow deflection actuator28 to move in one direction while preventing deflection actuator 28 frommoving in the opposite direction until a physician disengages or unlocksratchet system 27. In some examples, a mechanism other than ratchetsystem 27 may lock deflection actuator 28. In general, actuator 28 maytravel between a first position at which the lead tip is not deflectedand a second position at which the lead tip is fully deflected. In someexamples, actuator 28 may be configured to travel entirely from thefirst position to the second position, and vice versa, or stop atintermediate positions, corresponding to different degrees ofdeflection, during travel between the first and second positions.

Deflection actuator 28 may be integrated with housing 26 in IMD 24 andmay remain within IMD 24 within the patient following implantation.Deflection actuator 28 may be constructed of a soft rubber or plastic sothat the physician's thumb does not slip during the procedure. Otherergonomic features of housing 26 may be provided as well. For example,the sides of housing 26 may follow the contours of a hand or fingers. Inaddition, soft or rubber pads may be placed where housing 26 contactswith the hand to provide a secure gripping surface. In some examples,deflection actuator 28 may actuate a pull-wire that is ratcheted byratchet system 27. For example, when deflection actuator 28 is movedfrom a first position to a ratcheted position of ratchet system 27,deflection actuator 28 may pull (e.g., increase tension) on thepull-wire. As described in further detail below, the pull-wire may beconnected to the distal tip of lead 30 and, when pulled, may cause thetip of the lead to deflect. In this way, deflection actuator 28 mayactuate the pull-wire to deflect the tip of the electrical lead 30.Likewise, deflection actuator 28 may be pushed to thereby push thepull-wire and move the tip toward a non-deflected position, such as astraightened position relative to a major longitudinal axis of the lead.Alternatively, deflection actuator 28 and ratchet system 27 may bearranged in an opposite manner to that described above, such thatpushing of the deflection actuator 28 causes deflection of the distaltip of the lead 30 and pulling of the deflection actuator 28 causes thedistal tip of the lead 30 to move toward a non- deflected, e.g.,straightened, position. In either case, increasing pulling tension orpushing pressure on the pullwire increases deflection of the tip of lead30. Releasing tension on the pullwire may decrease deflection of the thetip of the lead 30. Deflection actuator 28 may be provided as anintegral component within housing 26 that may be implanted along withhousing 26 in IMD 24.

In some examples, ratchet system 27 may allow for movement of theactuator 28 in one direction while preventing movement in the oppositedirection. For example, ratchet system 27 may allow for incrementaltranslation of actuator 28 in a proximal or distal direction whilepreventing reversal of the movement, thus allowing deflection of lead 30without allowing reversal of the deflection. Ratcheting system 27 mayinclude a linear rack of teeth and a spring-loaded pawl, coupled to or apart of actuator 28, that engages with the teeth. The teeth of the trackmay be asymmetrical to allow for the pawl to advance over the teeth inone direction but not the other and thus allow movement of actuator 28in one direction and not the other.

In certain examples, actuator 28 may be released from the ratchetingsystem to allow, for example, straightening of the lead 30. This may bedesirable in cases where a physician, for example, has determined thatit has displaced the lead 30 too far. Ratchet system 27 may include atrigger system that may engage with the pawl to release the pawl fromengagement with the teeth of the track such that actuator 28 may move ineither a proximal or distal direction. In some examples, the triggersystem may engage with the track to displace the track from engagementwith the pawl to allow for movement of actuator 28 in either a proximalor distal direction.

In some examples, ratchet system 27 may lock actuator 28 in place, andtherefore lock in place the deflection of the tip of lead 30 unless asufficient amount of force is applied to actuator 28 to enable actuator28 to be moved to a next position corresponding to a next position ofdeflection for the tip of lead 30. For example, actuator 28 may becoupled to or comprise the pawl and the pawl may engage with the teethof the track of ratchet system 27 at a plurality of positions along athumb (or finger) slide. Each position between a pair of teeth mayreceive the pawl of actuator 28 to engage the actuator 28 at acorresponding position along the slide.

Additionally, a locking mechanism may include one or more springs formaintaining the pawl in a particular position, and thus locking thepawl, the actuator, and the distal portion of lead 30 in place, and/orfor allowing the pawl to advance to different positions and thusunlocking the pawl, actuator, and the distal portion.

The teeth may be configured to provide resistance to movement along theslide. For example, the teeth may be of a shape and/or material toprovide resistance of movement past each tooth of the track. Forexample, when the pawl of actuator 28 are engaged with a particularposition between a pair of teeth, sufficient force may need to beapplied to actuator 28 to release the pawl of the actuator 28 from theposition and past the next tooth to advance the actuator 28. Eachposition between a pair of teeth on the track may correspond to adifferent deflection angle of the tip of lead 30. Thus, a physician mayneed to apply a sufficient amount of force to overcome the next tooth inthe current position and advance the actuator 28, and therefore the tipof lead 30, to the next position. The amount of force required toadvance the actuator 28 from one position to the next may be an amountthat may easily be applied by the physician but not likely to be appliedaccidentally by the physician or by collision of the actuator 28 withtissue of the patient.

Each time that the actuator 28 is advanced and locked into a position,the advancement and locking mechanism of ratchet system 27 may providetactile feedback to the physician to help the physician recognizeadvancement of the actuator 28 and corresponding deflection of the tipof lead 30 to assist with efficient implantation. For example,acceleration out of each position and deceleration into the next while aphysician's hand is in contact with the actuator 28 may provide tactilefeedback to the physician. Alternatively or in addition, the physicianmay receive auditory feedback in the form of a “click” or other noiseindicating advancement to a new position. Housing 26 may also includemarkers along side ratchet system 27 such that advancement of actuator28 to a new position results in placement of actuator 28 next to acorresponding marker, providing visual feedback to the physician. Thus,ratchet system 27 may provide tactile, auditory, and/or visual feedbackto the physician to indicate each of the plurality of ratchet positions.In these examples, the tactile feedback, auditory feedback, and/orvisual feedback from ratchet system 27 to the physician may also be anindication of the amount of deflection of the distal end of electricallead 30.

Lead 30 of IMD 24 may be covered by introducer 31 (e.g., a sheath) wheninserted into pelvis 10. Introducer 31 may be constructed of aninjection moldable plastic such as polystyrene, polypropylene,polycarbonate, or any other polymer. In some examples, lead 30 may becovered at least in part by introducer 31. Additionally oralternatively, in some examples, introducer 31 may be removable. Forexample, introducer 31 may be split apart, i.e., slit, after location ofthe distal tip of lead 30 near the sacral nerve. Slitting may permit theintroducer 31 to be withdrawn over the INS housing 26, which may have asignificantly larger size than the lead 30. In this manner, once lead 30is appropriately positioned near the sacral nerve, introducer 31 isremoved from lead 30 so that lead 30 remains positioned adjacent to thesacral nerve. Additional information regarding, for example, anintroducer or a removable introducer may be found in U.S. PatentApplication Publication No. US20130110201 A1, to Bonde et al., filed May2, 2013, entitled “Medical Devices for Trial Stimulation,” the entirecontents of which being incorporated herein by reference.

In some examples, prior to removing introducer 31 from around lead 30, aphysician may use INS 29 connected to the one or more electrode of lead30 to perform test stimulation to confirm the capture of the targetnerve by electrical stimulation pulses. For example, introducer 31 mayhave window-like apertures that allow the one or more electrodes at thedistal end of lead 30 to protrude through the introducer to engagepatient tissue and thereby deliver stimulation energy to perform thetest stimulation. Additionally or alternatively, in some examples,introducer 31 may be comprised of an electrically conducting materialthat allows some or all of the one or more electrodes at the distal endof lead 30 to deliver stimulation energy to perform test stimulation. Insome examples, introducer 31 may include a sleeve with one or moreelectrically insulating portions that may be rotated into occlude one ormore electrodes at the distal end of lead 30, the apertures ofintroducer 31, and/or the electrically conducting material of introducer31 after test stimulation is complete.

After confirming lead 30 has been placed near the sacral nerve, e.g., bymonitoring sensed signals or observing outward symptoms resulting fromeffective placement of the lead for stimulation, the physician mayremove introducer 31. In some examples, removal of introducer 31 mayallow lead 30 to be secured in place, e.g., with tines or otheranchoring structures that may expand outward from the lead uponwithdrawal of the introducer 31 and be embedded within tissue of thepatient. For example, tines may be disposed within a muscle coveringsacral foramen 20. Tines on the lead 30 may also be attached to othersurrounding tissue.

In some examples, during evaluation of stimulation therapy, housing 26of IMD 24 may be external to the patient, and at least a portion of thelead 30 may exit the patient's skin when attached to housing 26 of IMD24. In these examples, the physician may evaluate stimulation therapywith IMD 24 prior to implantation. In some examples, the lead 30 may bepre-connected to INS 29, such that a physician is not required toconnect the lead 30 to INS 29. In some examples, lead 30 may be packagedwith introducer 31 covering lead 30. In other examples, a physician maycover the lead 30 with introducer 31.

In this manner, in some examples, after a successful evaluation of thestimulation therapy, the physician may implant IMD 24 including INShousing 26 within the patient. In other examples, after an unsuccessfulevaluation of the stimulation therapy, the physician may reposition IMD24 by repositioning housing 26 and/or changing the deflection of lead 30using the technique described herein iteratively until a successfulevaluation is achieved and may then implant IMD 24, including INShousing 26, within patient. In other examples, IMD 24, including lead30, may be removed from the patient and a new device may be positionedand implanted according to particular needs.

The location of the implanted IMD 24 may vary according to the health,condition, and/or anatomy of the patient. Examples of possible locationsfor a chronic stimulator may include the lower back, buttocks, abdomen,or thigh. In each case, electrical stimulation is delivered through theone or more electrodes on lead 30 implanted adjacent to the sacral nervevia the technique described in this disclosure. INS 29 may be programmedto deliver electrical stimulation therapy appropriate for treatment ofurinary incontinence, sexual dysfunction, pelvic pain, or otherdisorders. In addition, IMD 24 may be implanted in any suitable locationin the body according to particular needs and INS 29 may be programmeddeliver electrical stimulation therapy appropriate for any suitable typeof treatment according to particular needs.

In some examples, one or more components of IMD 24 may be reusable toreduce equipment costs. For example, IMD 24 may be reusable as it may beremoved after an initial implantation and re-implanted. In someexamples, even though lead 30 may be pre- connected to housing 26, lead30 may be detachable. In some cases, lead 30 may be disposable.Alternatively, lead 30 may be autoclaved or radiologically or chemicallysterilized for use in implanting lead 30 into a different patient. A newor sterilized lead 30 may be attached to housing 26 to form theintegrated IMD 24 comprising the lead 30, INS 29, and actuator 28 forimplantation within a patient.

FIG. 2 is a schematic diagram illustrating the exemplary deflecting tipof lead 30 of FIG. 1 upon insertion through sacral foramen 20 to reachsacral nerve 38. In the example of FIG. 2, pelvis 10 includes sacrum 14,inferior pubic ramus 16, ischial tuberosity 18, sacral foramen 20, andischial spine 12. FIG. 2 shows an interior view of pelvis 10. Vertebrae32 are attached to sacrum 14 and protect the spinal cord (not shown) asit travels from the brain to pelvis 10. Sacral S2 nerve 34, sacral S3nerve 36, and sacral S3 nerve 38 emanate from the spinal cord out fromsacrum 14. Sacral nerves 34, 36, and 38 combine posterior of ischialspine 12 to form pudendal nerve 40. Pudendal nerve 40 branches intoperineal branch 42 and anal branch 44. Lead 30 is shown, covered byintroducer 31, tunneled through sacral foramen 20 into the interior ofpelvis 10 and adjacent to sacral S3 nerve 38.

Sacral S3 nerve 38 (also described as “sacral nerve 38”) may bedifficult to access using surgical techniques as it is located on theanterior side of sacrum 14. Sacral nerve 38 is surrounded by othernerves and important tissues, so accurate guidance of lead 30 may bedifficult without internal guides when inserting lead 30. Additionally,sacral foramen 20 is smaller in diameter than the obturator foramen andmay be more difficult to navigate. To aid in insertion, the physicianmay palpate structures of pelvis 10, use tactile feedback, or otherlandmarks of pelvis 10 to locate sacrum foramen 20 or any other sacrumforamen. In some examples, a physician may use fluoroscopy and/orultrasound to locate sacrum foramen 20.

Inserting lead 30 into pelvis 10 with a procedure as described hereinmay be beneficial over other methods to reach sacral nerve 38. Becausethere are no nerves passing over sacral foramen 20, it is unlikely thatlead 30 would disturb another nerve near sacral nerve 38. In addition,the physician needs only a simple hand motion to insert lead 30 adjacentto sacral nerve 38. Anatomical structures may also aid in guiding lead30 to the correct location.

While the shape of lead 30 simplifies sacral nerve isolation, othertechniques may be useful in fine adjustment of the position of lead 30.Instead of using strictly anatomical landmarks to position lead 30adjacent to sacral nerve 38, imaging techniques such as fluoroscopy maybe used in some examples. The physician also may rely on tactilefeedback to guide placement, e.g., from lead 30 contacting ligaments,muscle bones or other structure. Alternatively, or additionally, IMD 24may use INS 29 as a test stimulator (not shown in FIG. 2) that produceselectrical stimulation to verify accurate lead placement relative to thesacral nerve. For example, as will be described in greater detail, IMD24 may include an electrical stimulation pulse generator in INS 29electrically coupled to electrodes carried by lead 30 via electricalconductors.

Lead 30 may have one or more electrodes near the distal tip of lead 30to deliver electrical pulses to sacral nerve 38. Lead 30 may includeconductors coupling the one or more electrodes and to contacts at ornear a proximal end of lead 30. The contacts may be coupled toelectrical circuitry of INS 29 to allow INS 29 to provide stimulationenergy to the electrodes of lead 30 for stimulation of tissue proximateto lead 30.

Lead 30 may include one or more electrodes arranged for unipolar,bipolar, and/or multipolar stimulation. For example, lead 30 may includeone or more electrodes at or proximal to its tip and housing 26 mayhouse at least one electrode used for unipolar stimulation with the atleast one or more electrodes of lead 30. As another example, lead 30 mayinclude a plurality of electrodes used for bipolar and/or multipolarstimulation. As another example, lead 30 may include a plurality ofelectrodes used selectively for unipolar stimulation, with one or moreelectrodes within housing 26, or for bipolar or multipolar stimulation.Any suitable combination of electrodes on lead 30 or in housing 26 maybe used for unipolar, bipolar, and/or multipolar stimulation accordingto particular needs.

Preferably, the majority of lead 30 may be electrically insulated sothat stimulation energy can be generally confined to the tip of lead 30.Hence, the one or more electrodes may be provided by an electricallyconductive lead 30 as described in FIG. 3 below. In certain examples, asdescribed below with reference to FIGS. 4A-4C, one or more dedicatedtesting electrodes may be formed at or near a distal tip of introducer31, e.g., by deposition, crimping, welding, or other fabricationtechniques, for use in testing placement of lead 30 before removal ofintroducer 31. Introducer 31 may have window-like apertures that allowthe one or more electrodes at the distal end of lead 30 to protrudethrough the introducer to engage patient tissue and thereby deliverstimulation energy to perform the test stimulation. Additionally oralternatively, in some examples, introducer 31 may be comprised of anelectrically conductive material that allows some or all of the one ormore electrodes at the distal end of lead 30 to deliver stimulationenergy to perform test stimulation. Thus, the physician may be able todeliver stimulation energy to test the placement of lead 30 whileintroducer 31 is still at least partially surrounding lead 30.

Upon delivery of test stimulation energy to the one or more electrodesof introducer 31 or lead 30, the physician may identify muscle movementassociated with appropriate sacral nerve stimulation to correctly placelead 30. Alternatively, electromyography may be performed with INS 29operating as the test stimulator to observe a compound muscle actionpotential (CMAP) which aids in correct placement of lead 30. In eithercase, INS 29 operating as the test stimulator aids the physician inpositioning lead 30 relative to sacral nerve 38.

Introducer 31 may be located around lead 30, and utilized whenimplanting lead 30. Lead 30 may reside within an inner lumen defined bythe introducer 31. The distal tip of lead 30 may be recessed from adistal end of introducer 31. The distal tip of introducer 31 may providea sharp point for penetration of tissue during the approach to thesacral nerve 38. In other examples, introducer 31 covering lead 30 maycomprise a dull or blunt point to limit tissue damage from contact witha sharp point. Once lead 30 is positioned correctly, introducer 31 maybe removed from lead 30 such that lead 30 remains in place and thedistal end of the lead 30 remains adjacent to sacral nerve 38. Lead 30may also be moved slightly after removal of introducer 31 for fineadjustment of the placement location. In some cases, the physician maydeflect the distal tip lead 30 to customize the shape of lead 30 totarget a desired nerve site. In some examples, as an alternative or inaddition to an introducer, lead 30 may include an internal stylet forfacilitating placement of lead 30 within the tissue and an introducer31.

In other examples, IMD 24 may be used to access other nerves in pelvis10. For example, lead 30 of IMD 24 may be inserted though sacral foramen20 to reach the nerve of the clitoris located near inferior pubic ramus16. IMD 24 may also be used to implant lead 30 near perineal branch 42or anal branch 44 of pudendal nerve 40. Lead 30 may be shaped slightlydifferently (e.g., with different deflection curves) to access nervesother than sacral nerve 38. In other examples, IMD 24 may be used toaccess nerves or other stimulation targets in other areas of the body.

FIG. 3 is a schematic diagram illustrating an exemplary lead 30 of IMD24 of FIG. 1 implanted through sacral foramen 20 and disposed adjacentto sacral nerve 38 after removal of introducer 31. In some examples,electrical lead 30 of IMD 24 may correspond to lead 30 of IMD 24 asdescribed in FIGS. 1 and 2.

As shown in FIG. 3, lead 30 is implanted adjacent to sacral nerve 38 inpelvis 10. As described in FIGS. 1 and 2, introducer 31 may be used toguide lead 30 adjacent to sacral nerve 38, e.g., for delivery ofstimulation energy to alleviate urinary incontinence, fecalincontinence, or sexual dysfunction. In some examples, after removal ofintroducer 31, test stimulation may be delivered from INS 29 of IMD 24,to ensure the one or more electrodes at the distal end of lead 30 arelocated in a correct position relative to sacral nerve 38. If thelocation of lead 30 is incorrect, lead 30 may be adjusted, eitherlongitudinally or rotationally, with the housing 26 of IMD 24, toprovide better electrical contact between the one or more electrodescarried by lead 30 and sacral nerve 38.

In the example of FIG. 3, introducer 31 has been removed, leaving lead30 disposed within a tunnel previously created by introducer 31. Lead 30may include tines or other structure to anchor lead 30 within tissue ofpelvis 10. The procedure for lead implantation provides secure anchoringtissue for the tines of lead 30. For example, tines may be securedwithin the muscle covering sacral foramen 20. Anchoring lead 30 withinthe muscle covering sacral foramen 20 may limit the amount of movementof lead 30 away from sacral nerve 38. In some examples, other anchormechanisms may be needed to secure lead 30 within the patient. Someexample anchor mechanisms may include screws, porous structures thatallow tissue in-growth, or sutures.

In some examples, lead 30 may be pre-connected to INS 29, which mayoperate as a trial and/or chronic electrical stimulator. In someexamples, lead 30 may be coupled to INS 29 external to the patient. WhenINS 29 is external to the patient, INS 29 may be used as a trialstimulator and permit the physician and the patient to evaluatestimulation efficacy before finalizing the implantation of IMD 24. Insome examples, if stimulation therapy is unsuccessful, the physician mayfurther adjust lead 30 of IMD 24. In other examples, if stimulationtherapy is unsuccessful, the physician may remove lead 30 from thepatient. In these examples, the physician may repeat the implantationtechnique as described herein until the stimulation therapy issuccessful.

In some examples, if stimulation therapy is tested and confirmed to besuccessful or if testing is not required, IMD 24 may be implantedbeneath the skin of the patient. When INS 29 is internal to the patient,INS 29 may operate as a chronic stimulator, which may provide, forexample, months or years of stimulation therapy with the use of lead 30.Lead 30 may be used by INS 29 when operating as a trial stimulator or achronic stimulator.

INS 29 within housing 26 of IMD 24 may be located at a variety oflocations within the patient. Preferably, housing 26 may be located nearlead 30 and in a location that does not interfere with patient activity.For example, housing 26 may be located in the abdomen, buttocks, lowerback, or thigh. In any location, lead 30 may be of sufficient length toreach sacral nerve 38 while coupled to INS 29.

In other examples, the distal end of lead 30 may be positioned adjacentother sacral nerves. For example, lead 30 may be inserted with a distalend positioned adjacent the nerve of the clitoris, e.g., for delivery ofelectrical neurostimulation to alleviate symptoms of sexual dysfunctionor incontinence. In any nerve location, lead 30 may be implanted throughsacral foramen 20. In some examples, however, lead 30 may not betunneled through sacral foramen 20.

In cases using IMD 24 for stimulation in other areas of the body, IMD 24may be implanted in areas that preferably do not interfere with patentactivity and allow for lead 30, being of any suitable length, to reachthe targeted stimulation area.

FIGS. 4A and 4B are views of an exemplary IMD 24 with lead 30 having adeflecting tip and a sliding actuator 28 configured to cause the tip oflead 30 to deflect to implant the lead 30 adjacent to a nerve. As shownin the top view of FIG. 4A, IMD 24 includes housing 26, ratchet system27, deflection actuator 28, INS 29, lead 30, and neck 48. Additionally,introducer 31 may surround at least a portion of lead 30 and may includesection 49 and introducer tip 50. In some examples, IMD 24, includinghousing 26, ratchet system 27, deflection actuator 28, INS 29, and lead30, and introducer 31 surrounding lead 30 may correspond to IMD 24,including housing 26, ratchet system 27, deflection actuator 28, INS 29,and lead 30, and introducer 31 surrounding lead 30 as described in FIG.1.

In the example of FIGS. 4A and 4B, housing 26 is generally rectangularin shape and has curved edges. Neck 48 securely attaches electrical lead30 to housing 26. Neck 48 may provide an attachment mechanism to enableelectrical lead 30 to be removed from neck 48. For example, neck 48 mayinclude spring-loaded terminals, set screws, or any other suitablemechanism for allowing removal of lead 30 from neck. Additionally, neck48 may reduce strain on lead 30. Detachment of lead 30 may be necessaryif lead 30 is to be disposable or sterilizable separate from housing 26.Alternatively, neck 48 may be permanently attached to electrical lead 30and neck 48 is removable from housing 26 by, for example, spring-loadedterminals, set screws, or any other suitable mechanism for removableattachment. In some examples, electrical lead 30 may be pre-connectedand/or permanently affixed to INS 29 of IMD 24. In some examples, neck48 may be pre-connected and/or permanently affixed to housing 26 of IMD24. In other words, electrical lead 30 and neck 48 may be connected andsecured to housing 26 of IMD 24 during manufacturing, such that thephysician is not required to make any physical or electrical connectionbetween electrical lead 30, INS 29, and housing 26 of IMD 24.

Lead 30 may include one or more electrodes 46A-C. The one or moreelectrodes 46A-C may be unipolar, bipolar, or multipolar and may be ringelectrodes, pad electrodes or segmented electrodes or any suitablecombination of different types of electrodes. Lead 30 may includeconductors for coupling the one or more electrodes 46A-C to terminals ator proximal to the distal end of lead 30 coupled to INS 29.

Introducer 31 of lead 30 may facilitate entry through the tissue of thepatient and enables access to sacral nerve 38. In some examples,introducer tip 50 may be used to pierce tissue and create a tunnelthrough pelvis 10. Introducer tip 50 may be shaped similar to a wedge,cone, pyramid, or any other shape that includes decreased surface areaat the distal end of introducer 31 to define a sharp point.

Section 49 of introducer 31 may be located near or on tip 50 for teststimulation during placement of lead 30. In some examples, section 49may include one or more distal electrodes formed on introducer 31 andconnected to INS 29 to perform test stimulation. In other examples,section 49 of introducer 31 may be a window-like aperture that exposes aselected portion of lead 30 and defines one or more electrode regionseither at distal tip 50 or displaced some distance from distal tip 50that allow one or more electrode of electrodes 46A-C of lead 30 toprotrude to stimulate tissue outside of introducer 31. In yet otherexamples, section 49 may be an electrically conductive material thatallows some or all of the one or more electrodes 46A-C on lead 30 toperform test stimulation while introducer 31 is still at least partiallysurrounding lead 30. Section 49 may be cylindrical, circular, orrectangular in shape. Alternatively, in some examples, introducer 31 mayhave more than one section 49. In these examples, the majority ofintroducer 31 may be an electrically insulative sheath or sleeve. Insome examples, section 49 may be located at a distal end of introducer31 and coupled to an electrical conductor within electrical lead 30. Insome examples, section 49 may be one of a plurality of sections ofintroducer 31 including one or more test electrodes on introducer 31 orallowing for exposure of the one or more electrodes 46A-C on lead 30 totissue.

In some examples, introducer 31 may be hollow and open at tip 50. Inthese examples, a hollow introducer 31 may permit the flow of a fluid tothe tissue to lubricate or anesthetize the surrounding tissue or reducetissue damage as introducer 31 is inserted into the patient.

Lead 30 may vary in length. Different sized patients may requiredifferent sizes of lead 30. In general, the length of lead 30 may be ina range of approximately 1 cm to 50 cm. More specifically, the length oflead 30 may be in a range of approximately 10 cm to 20 cm. In somecases, the length of lead 30 may be approximated by the height of thepatient. In other cases, one length of lead 30 may be appropriate forany sized patient. Generally, the diameter of lead 30 may be in a rangeof approximately 0.5 mm to 3.0 mm.

In some examples, housing 26 may be formed in a cylindrical, spherical,or other ergonomic shape designed to be held by one hand. A generallycylindrical housing 26 shape may provide the most flexibility to aphysician using IMD 24. In other words, the physician may hold housing26 at any circumference to direct lead 30 to any location. A cylindricalhousing shape may also allow the physician to easily manipulate IMD 24when attempting to position and deflect lead 30 near sacral S3 nerve 38.For example, the physician may readily move housing 26 longitudinallyand rotationally, as needed, during the process.

Housing 26 may generally be in a range of approximately 10 mm to 30 mmin length, 0.5 mm to 10 mm in width, and 0.5 mm to 5 mm in thickness.Preferably, housing 26 may be in a range of approximately 10 mm to 15 mmin length, 2 mm to 4 mm in width, and 1 mm to 3 mm in thickness. Housing26 may be provided in different sizes to accommodate INS 29 anddifferent sized hands of varying physicians. In addition, housing 26 maybe made to accommodate use in a right or left hand, either asambidextrous or separate models.

Housing 26 may be constructed of an injection moldable plastic such aspolystyrene, polypropylene, polycarbonate, or any other polymer. In someexamples, housing 26 may be constructed of a metal alloy includingstainless steel, titanium, aluminum, or a composite material. Thematerial used to construct housing 26 may be dependent on the intendedlife of IMD 24.

In some examples, introducer 31 may be constructed of a plasticmaterial. In these examples, an electrical conductor may be providedwithin introducer 31 for conduction of stimulation energy to one or moreelectrodes (e.g., section 49) formed at or adjacent to distal tip 50 ofintroducer 31. For some examples, one or more electrodes 46A-C onelectrical lead 30 may act as an electrical conductor within introducer31 for conduction of stimulation energy to the one or more electrodes ofintroducer 31. Electrodes formed at or adjacent to distal tip 50 ofintroducer may be unipolar, bipolar, or multipolar.

In some examples, the outer layer of lead 30 may be constructed of apolymeric material such as polyurethane or poly(dimethyl siloxane), afluoropolymer, and/or co- polymers including any combination of thesematerials. In these examples, one or more electrical conductors may beprovided within lead 30 for conduction of stimulation energy from INS 29to one or more electrodes 46A-C formed at or adjacent to distal tip 50of introducer 31. As illustrated in FIG. 4A, deflection actuator 28 maybe in a first position when the distal end of electrical lead 30 is notdeflected. However, in some examples, the distal end of electrical lead30 may be deflected by a physician with deflection actuator 28.

In operation, in some examples, a physician may penetrate a sacralforamen with distal tip 50 of introducer 31 and translate deflectionactuator 28 on housing 26 to deflect electrical lead 30 withinintroducer 31. In these examples, the physician may move lead 30 intothe interior of the pelvis such that distal tip 50 of introducer 31 isplaced adjacent to a desired nerve site (e.g., the sacral nerve). Insome examples, deflection actuator 28 may also have a locking mechanism,in addition to ratchet system 27, discussed above with reference to FIG.1, which can lock the deflection caused by deflection actuator 28. Forexample, deflection actuator 28 may be translated to deflect the distalend of lead 30 and rotated to lock in place the deflection caused by thetranslation of deflection actuator 28. For example, actuator 28 may berotated so that actuator 28 no longer engages with the thumb (or finger)slide described, above with reference to FIG. 1, but instead engageswith a stop that prevents translation of actuator 28 with respect tohousing 26.

In some examples, after locking deflection actuator 28, the physicianmay remove introducer 31 from the patient and implant IMD 24 into thepatient. Additionally, in some examples, after implantation of IMD 24,the physician may later remove the implanted IMD 24 from the patient andunlock deflection actuator 28 in order to change the deflection of thedistal end of electrical lead 30. In these examples, the change in thedeflection of the distal end of electrical lead 30 may lead to a betterplacement of electrical lead 30 near the sacral nerve.

For example, as illustrated in FIG. 4B, deflection actuator 28 may beactuated (e.g., translated) to a position other than the first positionto deflect the distal end of electrical lead 30. In some examples,deflection actuator 28 may be connected to a pull-wire within ratchetsystem 27. Ratchet system 27 may allow deflection actuator 28 to ratchetthe pull-wire at a plurality of ratchet positions, thereby deflectingthe distal end of lead 30 according to the plurality of ratchetpositions. Advancing the actuator 28 to each position within ratchetingsystem 27 may result in tactile feedback, in the form of accelerationout of each position and deceleration into the next while a physician'shand may be in contact with the actuator, and/or auditory feedback, inthe form of a “click” or other noise indicating advancement to a newposition. Housing 26 may also include markers along side ratchet system27 such that advancement of actuator 28 to a new position results inplacement of actuator 28 next to a corresponding marker, providingvisual feedback to the physician. Thus, ratchet system 27 may providetactile, auditory, and/or visual feedback to the physician to indicateeach of the plurality of ratchet positions. In these examples, thetactile feedback, auditory feedback, and/or visual feedback from ratchetsystem 27 to the physician may also be an indication of the amount ofdeflection of the distal end of electrical lead 30.

Deflection actuator 28 may be constructed of a soft rubber or otherelastomeric material to provide comfort and friction between the thumbof a physician and deflection actuator 28. As shown between FIGS. 4A and4B, movement of actuator 28 to the position shown in FIG. 4B may causelead 30 to be deflected to form bend 51. In some examples, electricallead 30 may have magnetic resonance imaging (Mill) shielding (e.g., anMill braid) that may increase the stiffness of electrical lead 30 up tobend 51 so actuation of deflection actuator 28 may cause the distal endof electrical lead 30 to deflect and form bend 51. In some examples,deflection actuator 28 may also indicate the deflection orientation ofthe distal end of electrical lead 30. In some examples, lead 30 may havea radius of curvature about bend 51 in a range of approximately 1 mm to40 mm, and more preferably approximately 1.5 mm to 25 mm, to permit easeof insertion to the desired nerve site. In some examples, bend 51 may belocated closer or further from electrodes 46A-46C. In some examples,bend 51 may be proximate to electrodes 46A-46C, and the radius ofcurvature may be in the range of approximately 5 mm to 15 mm. In someexamples, bend 51 may be proximate to electrodes 46A-46C, and the radiusof curvature may be in the range of approximately 15 mm to 35 mm. Insome examples, of the deflected tip of lead 30, for example, the portionof lead 30 between bend 51 and the distal end of lead 30 shown in FIG.4B, may be in the range of approximately 5 mm to 40 mm, and morepreferably approximately 7 mm to 20 mm, to allow suitable placement oflead 30 adjacent to a target nerve or nerves. In some examples,deflected tip of lead 30 may be deflected in the range of 10 degrees to60 degrees from the major longitudinal axis of the lead 30, and morepreferably approximately 35 degrees to 50 degrees, to allow suitableplacement of lead 30 adjacent to a target nerve or nerves.

In certain examples, actuator 28 of housing 26 may be provided indifferent sizes and configurations to accommodate different sized handsand/or use of a right or left hand, either as ambidextrous or separatemodels.

FIG. 5 is a view of an exemplary IMD like that shown in FIGS. 4A and 4Band additionally including a pulley 33. Pull wire 23 may extend from thetip of lead 30 to a pulley 33 proximal to actuator 28 and then toactuator 28 such that that distal translation of actuator 28 withrespect to housing 26 may result in increased tension on pull wire 23and deflection of the tip of lead 30 and proximal translation of theactuator 28 with respect to housing 26 may result in reduced tension inpull wire 23 and straightening of the tip of lead 30.

FIGS. 6A and 6B show perspective and cross-sectional views of anexemplary ratcheting system of the IMDs of FIGS. 1 and 4A-4C. Theratcheting system 27 may include a linear rack of teeth 25 and aspring-loaded pawl 75, coupled to or a part of actuator 28, that engageswith the 25 teeth.

Actuator 28 may be coupled to or comprise the pawl 75 and the pawl 75may engage with the teeth 25 of ratchet system 27 at a plurality ofpositions along a thumb (or finger) slide. Each position between a pairof teeth 25 may receive the pawl 75 of actuator 28 to engage theactuator 28 at a corresponding position along the slide.

The teeth 25 of the may be asymmetrical to allow for the pawl 75 toadvance over the teeth 25 in one direction but not the other and thusallow movement of actuator 28 in one direction and not the other. Asshown, pawl 75 is engaged between teeth 25 c and 25 d such that it isretained by wall 33 d of tooth 25 c to prevent movement of pawl 75 in adistal direction.

When the pawl 75 of actuator 28 is engaged with a particular positionbetween a pair of teeth 25, sufficient force may need to be applied toactuator 28 to release the pawl 75 of the actuator 28 from the positionand past the next tooth 25 to advance the actuator 28. Each positionbetween a pair of adjacent teeth 25 may correspond to a differentdeflection angle of the tip of lead 30.

Housing 26 may also include markers 35 along side ratchet system 27 suchthat advancement of actuator 28 to a new position results in placementof actuator 28 next to a corresponding marker 35, providing visualfeedback to the physician. Although markers 35 are shown as simplelines, markers 35 may include alternative or additional informationincluding, for example, a deflection angle associated with the portionfor the respective marker 35.

In some examples, ratchet system 27 may include a trigger system thatmay engage with the pawl 75 to release the pawl 75 from engagement withthe teeth 25 such that actuator 28 may move in either a proximal ordistal direction. In some examples, the trigger system may engage withthe rack of teeth 25 to displace the rack from engagement with the pawl75 to allow for movement of actuator 28 in either a proximal or distaldirection.

In some examples, a locking mechanism may include one or more springsfor maintaining the pawl 75 in a particular position, and thus lockingthe pawl 75, the actuator 28, and the distal portion of lead 30 inplace, and/or for allowing the pawl 75 to advance to different positionsand thus unlocking the pawl 75, actuator 28, and the distal portion.

FIG. 7 shows a perspective view of another exemplary ratcheting systemof the IMDs of FIGS. 1 and 4A-6B. As described with respect to FIGS. 6Aand 6B, the ratcheting system 27 may include a linear rack of teeth 25and a spring-loaded pawl 75, coupled to or a part of actuator 28, thatengages with the 25 teeth. A suture 79 may be used to release pawl 75from the teeth 25 such that pawl 75 may be moved in a proximaldirection. In some examples, suture 79 may be used to release pawl 75from the teeth 25 such that pawl 75 may be moved in a distal direction,according to particular needs. Suture 35 may pass through a lumen inpawl 75 or may otherwise be temporarily or permanently coupled to pawl75. In some examples, suture 79 may be coupled to pawl 75 when neededand removed when not needed.

FIG. 8 shows a perspective view of an exemplary AVID like that shown inFIGS. 1 and 4A-7 and additionally including a tool 37 for holding theactuator 28, which may be in the form of a collar, of the IMD in place.Tool 37 may be used to hold the device in place and capture the actuator28, thus allowing a practitioner to push on the proximal end of thehousing 26 to pull the pull-wire with respect to the housing 26 andgenerate (and/or lock) deflection of the lead 30.

In some examples, a practitioner may grasp the tool 37 with thepractitioner's fingers and may push on the proximal end of the housing26 with the practitioner's thumb.

FIG. 9 shows a perspective view of an additional exemplary ratchetingsystem 43 of the IMD of FIG. 1. Housing 81 of the IMD may include a setscrew 83 engaged with a rectangular key 41 that may be in a slottedkeyway 45 of the housing 81. The rectangular key 41 may be attached tothe pull-wire 39. A tool 85 may be used to rotate the set screw 83.Rotation of the set screw 83 may move the key 41 in a proximal or distaldirection and thus increase of decrease tension on the pull wire 39 anddeflect or straighten the lead.

FIGS. 10A, 10B, and 10C show perspective and side cross-sectional viewsof an additional exemplary ratcheting system 87 of the IMB of FIG. 1. Agear 63 may include a plurality of teeth 69 that may engage with a rack58 of teeth 67. The rack 58 may be coupled to pull-wire 55. The gear 63and rack 58 may be within housing 47. When rotated, the gear 63 maydisplace the rack 58, thus displacing the pull-wire 55 and causingdeflection or straightening of the lead. The gear 63 may include arecess 65 with which a tool 64 may be configured to engage such thatrotation of the tool 64 may result in rotation of the gear 63 anddeflection or straightening of the lead.

FIGS. 11A and 11B show perspective and side cross-sectional views of anadditional exemplary ratcheting system 93 of the IMD of FIG. 1. Similarto the ratcheting system 87 of FIGS. 10A-10C, a gear 92 may include aplurality of teeth 80 that may engage with a rack 88 of teeth 79. Thegear 63 and rack 58 may be within housing 65. The rack 88 may be coupledto pull-wire 72 and to a pull ring 89. A practitioner may displace thepull-ring 89 in a proximal direction with respect to the housing 47 todisplace the rack 88 in the proximal direction with respect to thehousing 65 and increase tension on the pull-wire 72, causing deflectionof the lead

The gear 92 may be a part of a gear assembly 91 further including aninner rod 73 about which the gear 92 rotates. The inner rod 73 mayinclude a pawl 77 and the gear 92 may include a recess 71. The pawl 77may be configured to engage with the recess 71 to allow rotation of thegear 92 in one direction but not the other. For example, in theillustrated example, the recess 71 and pawl 77 may engage to allowrotation of the gear 92 that allows for proximal movement of the rack 88but not distal movement of the rack 88. This may allow for deflection ofthe lead but prevent straightening of the lead when it has beendeflected. In some examples, the gear assembly 91 may be configured suchthat, if desired, a practitioner may release the pawl 77 from engagementwith the recess 71 but such disengagement may require action on the partof the practitioner. In this way, unintended straightening of the leadmay be prevented.

FIGS. 12A-12E show views of another exemplary IMD 52 with lead 30 havingdeflecting tip 60 and a rotating actuator configured to cause the tip 60to deflect to implant electrical lead 30 adjacent to a sacral nerve.FIG. 12A illustrates an internal view of IMD 52. In the example of FIG.12A, IMD 52 includes housing 53, keyed pull ring 54, pull-wire 57, lead30, shielding 59, tip 60, and bend 61. Although not shown in FIG.12A-12E, IMD 52 may be implanted using an introducer, such as introducer31 as described in FIGS. 4A and 4B.

Housing 53 may be substantially cylindrical in shape and may includekeyed pull ring 54 that is attached to pull-wire 57. As shown in FIG.12B, pull-wire 57 may extend along the body of lead 30 and/or may extendwithin housing 53. In the example of FIGS. 12A, 12B, 12C, 12D and 12Elead 30 may be deflected with deflection actuator 62 with resistancefrom shielding 59 to form a curved shape about bend 61 to facilitateentry through sacral foramen 20 and enable access to sacral S3 nerve 38.In some examples, shielding 59 may be magnetic resonance imaging (MRI)shielding (e.g., an Mill braid), which may be stiffer than tip 60 oflead 30. Housing 53 may house an INS (e.g., INS 29 as described in withreference to FIGS. 1, 4A, and 4B).

A tip of an introducer may be used to pierce tissue and create a tunnelthrough pelvis 10. Lead 30 covered by the introducer may be insertedinto the patient and twisted about a long axis of housing 53 to passthrough sacral foramen 20. In some examples, a physician may deflect tip60 of lead 30 within the introducer to facilitate accurate placement oflead 30 adjacent sacral S3 nerve 38.

In some examples, a section may be formed near or on the tip of theintroducer, e.g., by any of the techniques described with respect tosection 49 as described in FIGS. 4A and 4B, to provide for teststimulation during placement of lead 30. In these examples, the sectionmay be cylindrical, circular, or rectangular in shape. In some examples,the introducer covering lead 30 may be hollow and open near tip 60,e.g., to permit introduction of a fluid into the interior of pelvis 10.

In some examples, housing 53 may be cylindrical, spherical, or anotherergonomic shape designed to be held by one hand. A cylindrical housing53 shape may provide flexibility to a physician using IMD 52. Thephysician may hold housing 53 at any point about the circumference ofcylindrical housing 53 to direct lead 30 to any location. A cylindricalhousing shape may also allow the physician to easily rotate andmanipulate IMD 52 when attempting to position lead 30 near sacral S3nerve 38.

Similar in size to housing 26 discussed above with reference to FIGS. 4Aand 4B, housing 53 may generally be in a range of approximately 10 mm to30 mm in length, and 0.5 mm to 10 mm in diameter. In some examples,housing 53 may be in a range of approximately 10 mm to 15 mm in length,2 mm to 4 mm in width, and 1 mm to 3 mm in thickness. Housing 53 may beprovided in different sizes to accommodate both an INS (e.g., INS 29 asdescribed in FIG. 4A and 4B) and different sized hands of varyingphysicians.

Housing 53 may be constructed of materials similar to those describedwith reference to housing 26 as described in FIGS. 4A and 4B. In someexamples, a plastic material may be used to construct lead 30, whichinclude an electrical conductor for delivery of stimulation energy toone or more electrodes (not shown) at or near distal tip 60.

Lead 30 may include conductors coupling one or more electrodes on lead30 to contacts at or near a proximal end of lead 30 and the contacts maybe coupled to electrical circuit terminals of INS 29 to allow supply ofelectrical energy from INS 29 to the one or more electrodes of lead 30.

FIG. 12C illustrates an external view of IMD 52. FIG. 12D illustrates anexternal view of a portion of IMD 52. In the example of FIGS. 12C and12D, IMD 52 also includes neck 56 and deflection actuator 62. In someexamples, neck 56 securely attaches lead 30 to housing 53. In someexamples, neck 56 provides strain relief between lead 30 and housing 53.In some examples, neck 56 provides a seal between housing 53 and lead30.

In some examples, deflection actuator 62 may be provided on housing 53to facilitate deflection of the distal end of lead 30 by a physician.For example, deflection actuator 62 may be a knurled knob with internalthreads that can be turned to increase tension on pull-wire 57. In thisexample, housing 53 may have external threads 162 that are configured toengage with the internal threads of deflection actuator 62 such thatrotation of deflection actuator 62 may result in translation ofdeflection actuator 62 with respect to housing 53. Keyed pull ring 54may be part of deflection actuator 62 or may be positioned next todeflection actuator 62 or may otherwise receive force from deflectionactuator 62 such that translation of the deflection actuator 62 withrespect to housing 53 and lead 30 may result in translation of keyedpull ring 54 with respect to housing 53 and lead 30. Because keyed pullring 54 may be connected to pull-wire 57, translation of keyed pull ring54 away from tip 60 of lead 30 may increase tension on pull-wire 57 andresult in deflection of tip 60. Keyed pull ring 54 may include a keyedcomponent that may fit within a slot of housing 53 to prevent rotationof keyed pull ring 54 about housing 53 so that movement of keyed pullring 54 with respect to housing 53 is limited to translation withrespect to housing 53. In certain embodiments, pull wire 57 may extendsubstantially from the tip of lead 30 to keyed pull ring 54 such thatproximal translation of keyed pull ring 54 with respect to housing 53may result in increased tension on pull wire 57 and deflection of thetip of lead 30 and distal translation of the keyed pull ring 54 withrespect to housing 53 may result in reduced tension in pull wire 57 andstraightening of the tip of lead 30. In certain examples, pull wire 57may extend from the tip of lead 30 to a pulley mechanism proximal tokeyed pull ring 54 and then to keyed pull ring 54 such that that distaltranslation of keyed pull ring 54 with respect to housing 53 may resultin increased tension on pull wire 57 and deflection of the tip of lead30 and proximal translation of the keyed pull ring 54 with respect tohousing 53 may result in reduced tension in pull wire 57 andstraightening of the tip of lead 30.

Deflection actuator 62 may employ a ratcheting system similar toratcheting system 27 described with reference to FIG. 1. For example,keyed pull ring 54 may include or be coupled to a spring-loaded pawl.For example, the keyed portion of key pull ring 54 may include a pawland the slot of housing 53 may include a track of teeth configured toengage with the pawl and allow for incremental movement of the key pullring 54, provide for suitable resistance to movement to preventaccidental movement, provide for tactile, auditory, and/or visualfeedback for the physician, and may prevent movement in an oppositedirection. The ratchet system may also include a trigger system that mayengage the pawl to release it from engagement with the track and allowfor movement in both directions to allow for straightening, or decreaseddeflection, of the lead 30. The ratchet system may include a triggersystem that may displace the track from displace the track fromengagement with the pawl and allow for movement of the keyed pull ringin both directions and straightening or reduced deflection of the lead30.

FIG. 12E illustrates an internal view of IMD 52 showing keyed pull ring54 which may include a keyed portion (not shown) fitting within slot 160of housing 53, as described above with reference to FIG. 12C and 12D.

In operation, in some examples, a physician may penetrate a sacralforamen with a distal tip of an introducer and rotate deflectionactuator 62 on housing 53 to deflect tip 60 of lead 30. In theseexamples, the physician may move lead 30 into the interior of the pelvissuch that distal tip 60 is placed adjacent to a desired nerve site(e.g., the sacral nerve). In some examples, deflection actuator 62 mayalso be translated to lock the deflection caused by deflection actuator62. For example, keyed pull ring 54 may be translated into a detent thatprevents translational movement of keyed pull ring 54 and thus preventsstraightening or deflection of the tip of lead 30. Conversely, in otherexamples, deflection actuator 62 may be translated to deflect distal tip60 of lead 30 and rotated to lock the deflection caused by deflectionactuator 62. For example, the keyed pull ring 54 may be rotated suchthat the keyed portion is rotated into a groove perpendicular to slot160 so that the keyed portion is no longer in the slot and the grooveacts as a stop for keyed pull ring 54 to prevent distal or proximaltranslation of keyed pull ring 54, thus preventing straightening oradditional deflection of the tip of lead 30.

In some examples, after locking deflection actuator 62, the physicianmay remove the introducer from the patient and implant IMD 52 into thepatient. Additionally, in some examples, after implantation ofcylindrical IMD 52, the physician may later remove the implanted IMD 52from the patient and unlock deflection actuator 62 in order to changethe deflection of distal tip 60 of lead 30. In these examples, thechange in the deflection of distal tip 60 of lead 30 may result inbetter placement of lead 30 near the sacral nerve.

Although particular types of actuator configurations have been describedwith reference to FIGS. 4A-12E, other suitable actuator configurationsmay be used according to particular needs. For example, an actuator maybe in the form of a thumbwheel configuration that may transfer rotationof the thumbwheel to translation of a pull-wire, such as pull-wire 57,with respect to tip of a lead, such as lead 30, to cause displacement ofthe tip of the lead. Such a configuration may include a pinion gear orworm gear for translating the rotation of a thumbwheel to a translationof a member, such as a rack or worm gear, coupled to the pull-wire.

FIG. 13 shows a view of an exemplary IMD 24 with lead 30 having adeflected tip. IMD 24 may include housing 26 comprising INS 29 andactuator 28 coupled to lead 30 and introducer 31 at least partiallysurrounding lead 30. Lead 30 may be deflected at bend 51. A firstportion of lead proximal to bend 51 may extend substantially along afirst axis 101. A second, deflected portion of lead 30 distal to bend 51may extend substantially along a second axis 102. The angle “A” formedbetween the first axis and the second axis may be in the range of 10degrees to 60 degrees, according to particular needs. Although lead 30is shown to be deflected away from a side of IMD 24 having actuator 28,lead 30 may be configured to deflect in any suitable direction accordingto particular needs.

FIGS. 14A-14C are conceptual diagrams illustrating exemplary electricalleads with deflecting tips useful in the examples of FIGS. 1-13 andfurther including tines to secure the lead within a patient.

As shown in FIG. 14A, lead 99 includes housing 66, tines 68A, 68B, 68C,and 68D (collectively tines 68), and electrodes 70A, 70B, 70C, and 70D(collectively electrodes 70). Lead 99 may be a standard lead thatincludes all four tines 68 close to electrodes 70. Implanting lead 30may be beneficial due to tines 68 being anchored close to electrodes 70.A smaller distance between tines 68 and electrodes 70 may allow lessmovement of electrodes 70 with respect to adjacent sacral S3 nerve 38.

Electrodes 70 may be more effective in delivering electrical stimulationwhen the electrodes are located close to sacral S3 nerve 38. Ifelectrodes 70 migrate away from sacral S3 nerve 38, efficacy ofstimulation therapy may decrease. Therefore, tines 68 located close toelectrodes 70 may be beneficial to therapy efficacy. However, tines 68may not be capable of anchoring into a solid tissue if they are locatedtoo close to electrodes 70.

FIG. 14B illustrates a lead 103 which includes housing 78, tines 74A,74B, 74C, and 74D (collectively tines 74), and electrodes 76A, 76B, 76C,and 76D (collectively electrodes 76). Tines 74 are located a distance Daway from the most proximal electrodes 76. Lead 103 may be capable ofanchoring tines 74 in a muscle while enabling electrodes 76 to reachfurther away from the anchoring point to sacral S3 nerve 38. Distance Dmay be generally in a range of approximately 0.5 mm to 10 mm, and morepreferably 1 mm to 4 mm. While lead 103 may provide a more secureanchoring point, electrodes 76 may be free to migrate to an unacceptabledistance away from sacral S3 nerve 38.

FIG. 14C illustrates a lead 105 which includes housing 82, tines 84A,84B, 84C, 84D, 84E, 84F, 84G, and 84H (collectively tines 84), andelectrodes 86A, 86B, 86C, and 86D (collectively electrodes 86). Theincreased number of tines 84 located on lead 30 may provide secureanchoring in a muscle and soft tissue closer to sacral S3 nerve 38. Lead105 may be capable of providing better anchoring points and eliminatingmigration of electrodes 86 with respect to sacral S3 nerve 38. However,removal of lead 105 may injure a greater volume of tissue. Therefore,lead 105 may be more appropriate for patients with more activelifestyles where lead migration may be a problem.

In any of lead of FIGS. 14A-14C, any number of electrodes or tines maybe implemented. Although the lead includes four electrodes in each ofthe examples illustrated in FIGS. 14A-14C, a lead may include one, two,four, eight or more electrodes. In addition, any number of tines may beused. Also, in some cases, it may be desirable to deploy two or moreleads, each carrying one or more electrodes. Any of these configurationsmay be possible and desirable when implanting a lead to stimulate sacralS3 nerve 38 via the approach described in this disclosure.

In certain examples, tines may be flexible and may fold, toward a lead,to assume a low profile around the lead when introducer 31 issurrounding the lead and may unfold to positions extending substantiallyradially from the lead, as illustrated in FIGS. 14A-14C, when introducer31 is removed.

The tines illustrated in these examples may be used in combination withany suitable lead deflection mechanism described herein.

FIGS. 15 and 16 are block diagrams illustrating exemplary electricalstimulators, INS devices 29A and 29B, configured for use with a leadwith a deflecting tip in an IMD useful in the examples of FIGS. 1-14C .Components of INS devices 29A and 29B may be within housing 90 of an IMD(e.g., similar to housing 26 of IMD 24 or housing 53 of IMD 52).Components within housing 90 include processor 104, memory 106, pulsegenerator 108, and telemetry interface 110. In other examples, housing90 of INS devices 29A and 29B may include a greater or fewer number ofcomponents. In some examples, INS device 29A may be an active INS devicehaving power source 112, which may include a battery. By contrast, insome examples, INS device 29B may be a passive INS device having powercircuitry 109 and capacitors 113 and may not include a battery. Powercircuitry 109 and capacitors 113 may be charged by an externalprogrammer. In other examples, an INS device may include both active andpassive components, such that an INS device may include power circuitry109 and capacitors 113 in addition to power source 112.

In some examples, processor 104 may include one or more processorsconfigured to perform the operations needed to generate and deliver testand therapy stimulation signals to the patient. In various examples, INSdevices 29A and 29B may include one or more processors 104 or othercontrol hardware within housing 90, such as one or more microprocessors,digital signal processors (DSPs), application specific integratedcircuits (ASICs), field programmable gate arrays (FPGAs), or any otherequivalent integrated or discrete logic circuitry, as well as anycombinations of such components.

Memory 106 stores instructions for execution by processor 104,stimulation parameters and, optionally, information related to the useof lead 30. Memory 106 may include separate memories for storinginstructions, stimulation parameter sets, and stimulation information,or a common memory. In some examples, memory 106 may be random accessmemory (RAM), read only memory (ROM), programmable read only memory(PROM), erasable programmable read only memory (EPROM), electronicallyerasable programmable read only memory (EEPROM), flash memory,comprising executable instructions for causing the one or moreprocessors to perform the actions attributed to them.

In some examples, pulse generator 108 may be programmed with stimulationpulse parameters appropriate for delivery of test stimulation in theform of stimulation pulses delivered continuously or in selected burstsvia one or more of electrodes 70A-70N on lead 30. Additionally, in someexamples, pulse generator 108 may be a trial or chronic stimulator usedto treat the patient, such that pulse generator 108 may also beprogrammed with stimulation pulse parameters appropriate for delivery ofstimulation therapy via electrodes 70A-70N on lead 30. In some examples,electrodes 70A-70N on lead 30 may correspond to the one or moreelectrodes on lead 30 as described in FIGS. 3-5.

Processor 104 controls pulse generator 108 to deliver electricalstimulation therapy via electrodes 70A-70N on lead 30. Based onstimulation parameters programmed by the physician through telemetryinterface 110, processor 104 instructs appropriate stimulation by pulsegenerator 108. Information may also be received from telemetry interface110 at any time during operation, in which case a change in stimulationparameters may immediately occur. In some examples, telemetry interface110 may include a user interface that can be accessed directly, beforeimplantation of housing 90, as a set of switches, dials, buttons, and/orother input media. In some examples, telemetry interface 100 may includea user interface that may accessed, before and/or after implantation ofhousing 90, via an external programmer that transmits information to INSdevice 29A or 29B by telemetry interface 110 using any known wired orwireless telemetry. For example, wireless telemetry of telemetryinterface 110 in INS devices 29A and 29B may be accomplished by radiofrequency (RF) communication, Bluetooth, Near-Field Communication (NFC),or a proximal inductive interaction of INS devices 29A and 29B withanother programming device via telemetry interface 110. Processor 104may control telemetry interface 110 to exchange information with theprogramming device. Processor 104 may transmit operational informationand other information to the programming device via telemetry interface110.

Processor 104 may determine any pulse parameter adjustments based on thereceived information, and may load the adjustments into memory 106 foruse during delivery of stimulation. As mentioned above, the userinterface may include a series of switches, dials, or buttons forchanging stimulation parameters. The user interface may also include anLED or LCD display indicating the values of current stimulationparameters, battery life, and any operational information. As mentionedabove, the user interface may be provided by an external programmer thatmay be separate from IMB 24 and used to wirelessly control INS devices29A or 29B before, during, and/or after implantation.

In the example of FIG. 15, power source 112 may deliver operating powerto the components of INS device 29A. Power source 112 may include abattery and a power generation circuit to produce the operating power.In some examples, the battery may be rechargeable to allow extendedoperation. Recharging may be accomplished through proximal inductiveinteraction between an external charger and an inductive charging coil.

In the example of FIG. 16, INS device 29B may be a passive INS devicethat includes power circuitry 109 with coil 111 and capacitors 113instead of a battery or other power storage device. Additionalinformation regarding, for example, a passive INS device including powercircuitry may be found in U.S. Patent Application Publication No.US20130110201 A1, filed May 2, 2013, entitled “Medical Devices for TrialStimulation,” the entire contents of which being incorporated herein byreference. Alternatively or in addition, the components described hereinmay be powered by other suitable mechanisms. For example, any of thedevices described herein may be powered by transmission of acousticenergy (ultrasound).

In some examples, an INS device may include the power components of bothINS devices 29A and 29B. In these examples, the INS device may be anactive INS device prior to implantation to confirm the location ofelectrodes 70A-70N on lead 30 are located adjacent to the sacral nerveand a passive INS device after implantation. In this way, power source112 of the INS device may be limited to only allow for location of lead30 adjacent to the target nerve, whereas power circuitry 109 with coil111 and capacitors 113 may be not be limited in the same way as powersource 112 and instead may be used to provide chronic and trialstimulation.

FIG. 17 is a flow chart illustrating an example technique for implantingan implantable medical device with a deflecting lead tip adjacent to asacral nerve. FIG. 17 is described with reference to FIG. 1 but may beused for implantation of an implantable medical device in any exampledescribed herein and/or with any combination of features describedherein.

The technique, or procedure, is described to provide a physician with asimple, effective, and repeatable method for accessing a sacral nervedeep in pelvis 10 of a patient. Using lead 30 of IMD 24, a physician maypierce the skin of a patient's lower back or buttocks and tunnel lead 30toward and through sacral foramen 20 by using a forward and downwardmotion (114).

The physician may use the deflection actuator 28 to deflect a distal endof lead 30 to attempt to place the deflected distal end of lead 30adjacent to the sacral S3 nerve 38 (116).

The physician may perform test stimulation to determine correctplacement of lead 30 and capture sacral S3 nerve 38 (118). For example,electrodes on lead 30 exposed by apertures in introducer 31, asdescribed above with reference to FIGS. 4A and 4B, or electrodes withinintroducer 31, also as described with reference to FIGS. 4A and 4B, maybe used to apply test stimulation.

One or more responses to the test stimulation may be measured and/orobserved to determine whether placement of the lead 30 is successful(120). For example, muscle movement, sensation indicated by the patient,pain relief, electrical response measured by EMG and/or evoked fieldresponse, a bellows response by contraction of the levator ani visiblyor otherwise measurably lifting the pelvic floor and/or the analsphincter, and/or any other suitable response may be used to determinesuccessful stimulation of sacral S3 nerve 38 and successful placement oflead 30 within patient.

If the physician determines, based on the response or lack of responseto the test stimulation, that placement of lead 30 is not successful,the physician may reposition lead 30 by, for example, repositioning lead30 by movement of housing 26 and/or changing the deflection of thedistal portion of lead 30 using deflection actuator 28, to attempt tocapture sacral S3 nerve 38 (118). After repositioning, physician mayrepeat the steps of applying test stimulation (118) and determiningwhether placement is successful (120). The physician may repeat thesesteps of repositioning (122), applying test stimulation (118), anddetermining whether placement is successful (120) until the physiciandetermines that placement is successful or decides to remove lead 30 totry a new device and/or an alternative procedure or course of action.

In some examples, the physician may deflect the distal portion of lead(116), apply test stimulation (118), and look for feedback to determinesuccessful position (120) simultaneously.

If the placement of lead 30 is successful, the physician may continue toremove introducer 31 from lead 30 to expose electrical lead 30 (124). Insome examples, the physician may also lock deflection actuator 28 inplace before removing introducer 31. After removing introducer 31 fromlead 30, the physician may implant housing 26 of IMD 24 (126).

In some examples, cylindrical IMD 52 may be used instead of IMD 24. Theprocedure of FIG. 17 remains similar, with an alternative method ininserting lead 30 and implanting IMD 52. IMD 52 may allow for animproved twisting motion to tunnel the introducer covering lead 30through sacral foramen 20 and reach sacral S3 nerve 38.

In other examples, the procedure of FIG. 17 may be similar whenimplanting a lead near a different nerve of the pelvic floor. Forexample, the procedure may be substantially similar when accessing adifferent sacral nerve. However, reaching the nerve of a differentsacral nerve may require a slightly different deflection of lead 30 toappropriately position a lead adjacent to the nerve.

In addition, any of the described units, devices, or components may beimplemented together or separately as discrete but interoperabledevices. Depiction of different features as units or components isintended to highlight different functional aspects and does notnecessarily imply that such units or components must be realized byseparate hardware or software components. Rather, functionalityassociated with one or more units or components may be performed byseparate hardware or software components, or integrated within common orseparate hardware or software components.

Although particular dimensions of components have been described,components of any suitable dimensions may be used according toparticular needs.

When implemented in software, the functionality ascribed to thetechniques, devices, and systems described in this disclosure, such asthose described with respect to INS 29A and INS 29B with reference toFIGS. 15 and 16, may be embodied as instructions on a computer-readablemedium such as RAM, ROM, NVRAM, EEPROM, FLASH memory, magnetic datastorage media, optical data storage media, or the like. The instructionsmay be executed to support one or more aspects of the functionalitydescribed in this disclosure. In some examples, computer-readablestorage media may comprise non-transitory media. The term“non-transitory” may indicate that the storage medium is tangible and isnot embodied in a carrier wave or a propagated signal. In certainexamples, a non-transitory storage medium may store data that can, overtime, change (e.g., in RAM or cache).

The program code may be executed by one or more processors, such asprocessors 104 illustrated and described with reference to FIGS. 15 and16, which may include one or more DSPs, general purpose microprocessors,ASICs, FPGAs, or other equivalent integrated or discrete logiccircuitry. In this sense, the techniques are implemented in hardware,whether implemented entirely in hardware or in hardware such as aprocessor executing computer-readable code. Accordingly, the term“processor,” as used herein may refer to any of the foregoing structureor any other structure suitable for implementation of the techniquesdescribed herein.

Various examples have been described. These and other examples arewithin the scope of the following claims.

1-20. (Cancelled)
 21. An implantable medical device comprising: ahousing, including a channel disposed therein; a neurostimulatorassociated with the housing; a lead coupled to the housing, the leadincluding an electrode and one or more conductors coupling the electrodeto the neurostimulator; and an actuator coupled to the channel of thehousing, the actuator configured to cause at least a portion of the leadto deflect.
 22. The implantable medical device of claim 21, furthercomprising: a pull-wire connected to a distal portion of the lead andconnected to the actuator, wherein the actuator is configured such thatmovement of the actuator in a first direction increases tension on thepull-wire to cause the deflection of at least the distal portion of thelead.
 23. The implantable medical device of claim 21, the actuatorcomprising: a rotatable screw; and a key, configured to translate withinthe channel.
 24. The implantable medical device of claim 23, furthercomprising: a pull-wire connected to a distal portion of the lead andconnected to the key of the actuator, wherein the actuator is configuredsuch that rotation of the screw causes translation of the key within thechannel so as to increase or decrease tension on the pull-wire anddeflect or straighten at least the distal portion of the lead.
 25. Theimplantable medical device of claim 21, wherein the neurostimulator isconfigured to deliver electrical stimulation to the lead to providestimulation therapy to at least one nerve.
 26. The implantable medicaldevice of claim 21, wherein the actuator is configured to cause the leadto deflect from a first shape to a second shape, wherein the secondshape comprises a curve of a radius R in a range of approximately 1 mmto 40 mm.
 27. The implantable medical device of claim 21, wherein: thelead, when deflected, includes a first portion and a second portion, thefirst portion being not substantially deflected and extendingsubstantially along a first axis and the second portion beingsubstantially deflected and extending substantially along a second axis;the first axis and the second axis form an angle; and the angle is in arange of approximately 10 degrees to 60 degrees.
 28. The implantablemedical device of claim 21, wherein: the lead, when deflected, includesa first portion and a second portion, the first portion being notsubstantially deflected and extending substantially along a first axisand the second portion being substantially deflected and extendingsubstantially along a second axis, and the second portion has a lengthin a range of approximately 5 mm to 40 mm.
 29. The implantable medicaldevice of claim 21, wherein the lead includes a plurality of electrodesand a plurality of fixation members.
 30. The implantable medical deviceof claim 29, wherein the plurality of electrodes are arranged togetherin a group, and the plurality of fixation members are arranged togetherin a group, the group of electrodes being spaced apart from the group offixation members.
 31. An implantable medical device comprising: ahousing; a neurostimulator associated with the housing; a lead coupledto the housing, the lead including an electrode and one or moreconductors coupling the electrode to the neurostimulator; an actuatoroperably connected to the housing, wherein operation of the actuator isconfigured to cause at least a portion of the lead to deflect.
 32. Theimplantable medical device of claim 31, wherein the housing includesexternal threads, and wherein the actuator includes a knob havinginternal threads configured to engage with at least a portion of theexternal threads of the housing.
 33. The implantable medical device ofclaim 31, further comprising: a pull-wire connected to a distal portionof the lead and connected to the actuator, wherein the actuator isconfigured such that movement of the actuator in a first directionincreases tension on the pull-wire to cause the deflection of at leastthe distal portion of the lead.
 34. The implantable medical device ofclaim 33, the actuator further comprising: a pull ring connected to thepull-wire, wherein rotation of the knob results in translation of thepull ring and translation of the pull-wire with respect to the lead, soas to increase or decrease tension on the pull-wire and deflect orstraighten at least the distal portion of the lead.
 35. The implantablemedical device of claim 31, the actuator further comprising: a lockingmechanism configured to lock in place the deflection of the lead. 36.The implantable medical device of claim 35, wherein at least a portionof the actuator may be rotated to lock in place the deflection of thelead.
 37. The implantable medical device of claim 31, wherein theneurostimulator is configured to deliver electrical stimulation to thelead to provide stimulation therapy to at least one nerve.
 38. Theimplantable medical device of claim 31, wherein the actuator isconfigured to cause the lead to deflect from a first shape to a secondshape, wherein the second shape comprises a curve of a radius R in arange of approximately 1 mm to 40 mm.
 39. The implantable medical deviceof claim 31, wherein: the lead, when deflected, includes a first portionand a second portion, the first portion being not substantiallydeflected and extending substantially along a first axis and the secondportion being substantially deflected and extending substantially alonga second axis; the first axis and the second axis form an angle; and theangle is in a range of approximately 10 degrees to 60 degrees.
 40. Theimplantable medical device of claim 31, wherein: the lead, whendeflected, includes a first portion and a second portion, the firstportion being not substantially deflected and extending substantiallyalong a first axis and the second portion being substantially deflectedand extending substantially along a second axis, and the second portionhas a length in a range of approximately 5 mm to 40 mm.
 41. Theimplantable medical device of claim 31, wherein the lead includes aplurality of electrodes and a plurality of fixation members.
 42. Theimplantable medical device of claim 41, wherein the plurality ofelectrodes are arranged together in a group, and the plurality offixation members are arranged together in a group, the group ofelectrodes being spaced apart from the group of fixation members.
 43. Akit, comprising: an implantable neurostimulator including: a housing,including a channel disposed therein; a lead coupled to the housing, thelead including an electrode and one or more conductors coupling theelectrode to the housing; and an actuator coupled to the channel of thehousing, the actuator including a rotatable screw and a key, wherein thekey is configured to translate within the channel, a pull-wire connectedto a distal portion of the lead and connected to the key of theactuator; and a tool configured to engage the rotatable screw of theactuator, wherein the actuator is configured such that rotation of thescrew causes translation of the key within the channel so as to increaseor decrease tension on the pull-wire and deflect or straighten at leastthe distal portion of the lead.